Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death.  The issue stems from a manufacturing defect in certain units’ pump driver circuit assemblies, which contain capacitors rated below required specifications, according to an Aug. 27 news release from the FDA. 

The use of 25v-rated tantalum capacitors in place of 35v-rated components may result in reduced pump performance or sudden pump failure. In these cases, the device may trigger critical alarms, including “Impella Failure” or “Impella Stopped. Controller Failure.” A sudden drop in the pump performance could result in hemodynamic instability, loss of circulatory support or death.  Abiomed sent letters to affected customers recommending affected devices be immedia

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